NDC 0023-0667 Refresh P.m.
Mineral Oil, Petrolatum Ointment Ophthalmic

Product Information

What is NDC 0023-0667?

The NDC code 0023-0667 is assigned by the FDA to the product Refresh P.m. which is a human over the counter drug product labeled by Allergan, Inc.. The generic name of Refresh P.m. is mineral oil, petrolatum. The product's dosage form is ointment and is administered via ophthalmic form. The product is distributed in a single package with assigned NDC code 0023-0667-04 1 tube in 1 carton / 3.5 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0023-0667
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Refresh P.m.
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Mineral Oil, Petrolatum
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormOintment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Ophthalmic - Administration to the external eye.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Allergan, Inc.
Labeler Code0023
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		part349
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		08-26-2016
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Refresh P.m.?


Product Packages

NDC Code 0023-0667-04

Package Description: 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE

Product Details

What are Refresh P.m. Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • MINERAL OIL 425 mg/g - A mixture of liquid hydrocarbons obtained from petroleum. It is used as laxative, lubricant, ointment base, and emollient.
  • PETROLATUM 573 mg/g - A colloidal system of semisolid hydrocarbons obtained from PETROLEUM. It is used as an ointment base, topical protectant, and lubricant.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 702008 - mineral oil 42.5 % / petrolatum 57.3 % Ophthalmic Ointment
  • RxCUI: 702008 - mineral oil 0.425 MG/MG / petrolatum 0.573 MG/MG Ophthalmic Ointment
  • RxCUI: 702008 - mineral oil 42.5 % / petrolatum, white 57.3 % Ophthalmic Ointment

* Please review the disclaimer below.

Refresh P.m. Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts


Active Ingredients



Mineral Oil 42.5%

White Petrolatum 57.3%


Purpose



Eye lubricant

Eye lubricant


Uses



  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • May be used as a protectant against further irritation.

Warnings



  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

Otc - Stop Use



Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.


Other Information



  • Store away from heat.
  • Protect from freezing.
  • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
  • Use before expiration date marked on container.
  • Store at 59°-86°F (15°-30°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive Ingredients



Lanolin alcohols


Questions Or Comments?



1.800.433.8871

refreshbrand.com


Principle Display Panel



NDC 0023-0240-04

Preservative-free

Refresh

P.M.®
Lubricant Eye
Ointment

NIGHTTIME OINTMENT

Protects the eyes
from nighttime
dryness and exposure

Net wt. 0.12 oz (3.5 g) Sterile


* Please review the disclaimer below.